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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
510(k) Number K233932
Device Name Alinity i Toxo IgM
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Laura Fraczek
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Laura Fraczek
Regulation Number866.3780
Classification Product Code
LGD  
Date Received12/14/2023
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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